At Sanofi, this is an exciting time to join our Early Development Oncology team with our diversified and growing internal pipeline, enriched by the recent acquisitions. Our Oncology team is expanding to support our growing programs, and we seek candidates who want to create life-changing treatments for cancer patients.
This individual will report to the Project Lead or to the Head of Oncology Early Development, and will interface with all functions to support the development of novel anti-cancer therapeutics. This role is under the supervision of Project/Clinical Lead for all designated clinical study related activities including but not limited to preparation, execution, reporting, strategic decision-making, investigator/Ad Board/DMC/Other External Meeting, and regulatory submission/consultation.
Play a key role among a group of physicians and scientists particularly on studies with oncology assets in early development
Serve as Study Monitor on the assigned clinical trials, also functioning as critical connection ring between strategy and execution, acting as the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
Provide support to the Clinical Lead for the assigned trials
Closely interface with Clinical Operations, Regulatory, Biostatistics, TMED, PK, Data Mgmt and all functions related to study conduct
Support the Clinical Lead contributing to strategy, clinical development plans, review of pre-clinical packages
Ensure strategic execution according to the protocol and study plan (under direction of the Clinical Lead)
Support creating and communicating the vision for the Clinical Program
Design, implement, and interpret creative clinical trials whose outcomes define usage of the drug and create opportunities for a commercially successful product
Work transversally with colleagues from Development, Medical Operations, Clinical Operations, Translational Research, Pharmacology, Biomarkers, Statistics, Safety, Competitive Intelligence, and all other functions pertinent to the project, to harmonize translating the strategy into execution in assigned studies, to support updating the strategy based on competitive intelligence, early clinical data, new scientific knowledge, to prepare essential clinical study documents
Prepare and review synopses, protocols and amendments, the IB, clinical sections of IND/IMPD, CTAs filings, annual reports, clinical study reports, risk-management plans, and regulatory documents (INDs, NDAs) under the supervision of the Clinical Lead and Project Head
Assist in the preparation and conduct of study trainings for investigators, study sites, internal colleagues
Perform data interpretation and analysis to assess the impact on project objectives and deliverables
Participate in the preparation of registration clinical documentation (labeling, CTDs, overview summaries)
Prepare responses for clinical questions from health authorities
Provide feedback to the clinical study team regarding study conduct (contribute to discussions regarding adjustments in the study and/or strategy based on the data)
Under guidance from and in alignment with Clinical Lead, may act as a Dedicated Project Expert (DPE), and may mentor project Scientists
Closely monitor and support study start up, opening of sites, data collection
Support design and management of Advisory Boards (content and strategy), strategic committees, Data Monitoring Committee and any other ad-hoc committee meetings
Provide scientific support for clinical data review and interpretation including safety and efficacy
If asked, participate in meetings with health authorities for development and registration purposes
Author and review clinical abstracts and presentations for conferences when appropriate
Assess go/no go points for each indication
Manage relations with investigators and study sites
Possibly support transition of new preclinical assets to the clinic
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.